January 21, 2026
Post-marketing Clinical Monitoring Reporting. Reminder!
In accordance with Order No. 1113n of the Ministry of Health of the Russian Federation dated October 19, 2020, titled “On Approval of the Procedure for Reporting by Entities Involved in the Circulation of Medical Devices on All Cases of Identifying Side Effects Not Listed in the Instructions for Use or Operating Manual of a Medical Device, Adverse Reactions During Its Use, Specific Interactions Between Medical Devices, as Well as Facts and Circumstances That Pose a Threat to the Life and Health of Citizens and Medical Workers During the Use and Operation of Medical Devices”, Paragraph 8 stipulates the following:
After obtaining a registration certificate for a medical device of Risk Class 2b (applicable only to implantable medical devices) or Risk Class 3, the manufacturer (or the Authorized Representative of the Manufacturer of a medical device on the territory of the Russian Federation for foreign manufacturers) is obliged to submit an annual report (covering the preceding year) every January for a period of 3 years.
This means that by January, the manufacturer of a medical device must have compiled the following information:
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Sales statistics for the medical device.
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Usage statistics for the medical device.
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User feedback on the use of the medical device, covering the previously defined criteria for the device’s efficacy and safety.
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Statistics from literary sources and other databases demonstrating and proving the efficacy and safety of the medical device’s use.
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Statistics on adverse events/reports and other data regarding selected analogues of the medical device.
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Any other information the manufacturer of a medical device means necessary to prove the clinical efficacy and safety of their device in the Russian Federation.
Reporting deadline: by February 1st of each year.
Reporting period: the preceding calendar year.
Note: Even if a medical device was registered at the end of the year, a report must still be submitted in February of the following year.
Who should submit the report: domestic manufacturers, authorized representatives of foreign manufacturers of medical devices.
Where to submit: via the Roszdravnadzor website (https://roszdravnadzor.gov.ru) in the personal account section.
Which medical devices are covered: Medical devices of risk class 2b (implantable devices) and risk class 3, registered after 2020, or after amendments to the registration dossier related to:changes in the device design, changes in indications for use, changes in intended purpose, changes in contraindications, other clinically significant changes.
When does the reporting period end?
The reporting period for post-marketing clinical monitoring ends when Roszdravnadzor issues a conclusion (in response to the last submitted report) stating that the reporting period has been terminated.
Our team will assist you in preparing the necessary documents and submitting the reports on time. Don’t forget: submitting these reports is a mandatory requirement!
